Advancing Regulatory Science (+++++) INFORMATION ABOUT FDA'S REGULATORY SCIENCE RESEARCH

Advancing Regulatory Science https://www.fda.gov/science-research/science-and-research-special-topics/advancing-regulatory-science?utm_medium=email&utm_source=govdelivery Regulatory Science is a field of scientific research focused on developing the tools, standards, and approaches needed to generate the data and information on which FDA assesses the safety, efficacy, quality, and performance of FDA-regulated products. Advances in regulatory science are critical to support regulatory decision-making and to help enable the translation of discoveries in science and technology into safe and effective medical products. FDA: Overview of our Role Regulating and Approving Drugs | Video Series https://www.fda.gov/drugs/information-consumers-and-patients-drugs/overview-our-role-regulating-and-approving-drugs-video-series?utm_medium=email&utm_source=govdelivery FDA oversees prescription, generic, biosimilars, and over-the-counter drugs. Learn more. CDER Office of New Drugs- Regulatory Science Research https://www.fda.gov/about-fda/cder-offices-and-divisions/office-new-drugs-regulatory-science-research The Office of New Drugs (OND)-led regulatory science research projects are designed to address knowledge gaps identified during regulatory review of investigational or new drug applications. Learn more. CDER Office of Generic Drugs- Science and Research https://www.fda.gov/drugs/generic-drugs/science-research?utm_medium=email&utm_source=govdelivery The Office of Research and Standards within the FDA's Office of Generic Drugs (OGD) supports the Science and Research program established under the Generic Drug User Fee Amendments (GDUFA). In collaboration with industry and the public, FDA creates an annual list of its regulatory science initiatives on generic drugs. Learn more. Research Tools and Resources https://www.fda.gov/drugs/science-and-research-drugs/research-tools-and-resources?utm_medium=email&utm_source=govdelivery Developing and sharing knowledge and scientific resources with researchers in the public and private sectors is at the heart of what CDER scientists do. Learn more.